Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Confirmed diagnosis of symptomatic multiple myeloma
• •* Durie Salmon stage 2 or higher
• •* Previously untreated multiple myeloma (including immunomodulatory drugs such as thalidomide) with the exception of bisphosphonates
• •Evaluable or measurable disease, as defined by at least one of the following:
• •* Serum monoclonal protein ≥ 1 g/dL (measurable disease)
• •* Urine monoclonal protein ≥ 200 mg/24 hours by protein electrophoresis (measurable disease)
• •* Serum-free light chains (FLC) ≥ 10 mg/dL, kappa or lambda, accompanied by an abnormal kappa/lambda ratio
• •Serum FLC's should only be used for patients without measurable serum or urine m-spike
• •\- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
• •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
• •\- ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
• •Total bilirubin normal OR direct bilirubin ≤ 2.0 mg/dL
• •Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
• •AST ≤ 3 times ULN
• •Creatinine ≤ 3.5 mg/dL
• •Absolute neutrophil count ≥ 1,000/mm³ without transfusion or growth factor
• •Platelet count ≥ 100,000/mm³ without transfusion or growth factor
• •Willingness and the physical and mental capability to provide written informed consent
• •Willingness to return to Mayo Clinic Arizona/Princess Margaret Hospital for follow-up
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception